Surgical procedures increasingly require that the joint, limb or body part to be operated upon to be precisely and predictably positioned during such surgery. Optimum positioning requires a large range of positive positioning adjustments to be easily available so that the limb or joint to be treated is initially positioned and thereafter maintained in the desired position. Not only must such selected position be maintainable but also it is very important and often necessary that the limb be released and repositioned on demand during the course of the procedure to ensure optimum access thereby to require a variety of angular relationships for effective surgery.
Medical devices, including surgical equipment for holding a body part, that have contact with body tissues or fluids are considered critical items as these items should be sterile when used because any microbial contamination could result in disease transmission. If these items are heat resistant, the recommended sterilization process is steam sterilization, because it has the largest margin of safety due to its reliability, consistency, and lethality. Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. Sterilization destroys all microorganisms on the surface of an article or in a fluid to prevent disease transmission associated with the use of that item. Sterilization refers to any process that eliminates, removes and/or kills all forms of life, including transmissible agents such as fungi, bacteria, viruses, spore forms, etc. present on a surface, which can be achieved by applying heat, chemicals, irradiation, high pressure, and filtration or combinations thereof. The concept of what constitutes “sterile” is measured as a probability of sterility for each item to be sterilized. This probability is commonly referred to as the sterility assurance level (SAL).
Sterilization facilities are separate from operating rooms to perform heat sterilization on surgical equipment in an autoclave, sometimes called a converter. If sterilization is needed in the operating room, flash sterilization methods are used, for example, should the plate become unsterile for any reason then flash sterilization methods require placing in hot liquids to remove pathogens and afterwards instruments may take longer to reach the required room-temperature after sterilization while cooling thereby delaying the surgical procedure and adding cost.
Problems in sterilizing surgical equipment for holding a body part abound Disadvantages of previous surgical equipment for holding a body part include the costs associated with sterilization, whereby nooks and folds where residues accumulate and cannot be, or require increased effort to be, dislodged. Another design problem is in use of multiple parts, whereby the entire set of complex rails, tubes and other parts of the surgical equipment and apparatus required disassembly, scrubbing, power washing and other procedures that increased the cost of the sterilization and overall procedure. In addition, parts of the surgical equipment for holding a body part could get lost or removal may void warranties. In general, such surgical equipment for holding a body part during a surgical procedure required sterilization before entering an operating room. Once the surgical procedure ends, the surgical equipment again requires sterilization.
These problems involving the sterilization of surgical equipment have existed for a long period of time without solution. The problem also involves design and construction involving multiple parts such as, for example, complex rails, tubes and other apparatus secured to an operating table. As a result, a simplified design for surgical equipment for holding a body part is desired that reduces these and other disadvantages including the cost of the sterilization and overall time and cost of the procedure.